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Associate Director, Regulatory Medical Writing - Oncology - Job Opportunity at Johnson & Johnson

Leiden, Netherlands
Full-time
Senior
Posted: April 26, 2025
Hybrid
EUR 95,000 - 120,000 annually based on European pharmaceutical industry standards for senior regulatory positions

Benefits

Hybrid/Remote work flexibility offering work-life balance
Career development in a leading pharmaceutical company
Global exposure across multiple regions
Comprehensive healthcare benefits typical of J&J
Professional development and training opportunities

Key Responsibilities

Lead strategic medical writing initiatives across therapeutic areas with focus on oncology
Direct cross-functional teams for regulatory submissions and clinical documentation
Oversee document quality and compliance for regulatory submissions
Mentor and develop junior medical writers
Drive process improvements and best practices implementation
Represent Medical Writing function in high-level strategic meetings
Manage relationships with external contractors and stakeholders

Requirements

Education

University/college degree in scientific discipline required, advanced degree (Masters, PhD, MD) preferred

Experience

10 years pharmaceutical/scientific experience, 8 years clinical/regulatory medical writing experience required

Required Skills

Advanced knowledge of ICH requirements Expert project management skills Strong leadership and people management capabilities Excellent oral and written communication Problem-solving and risk mitigation expertise Cross-functional team coordination Process improvement and change management Time management and organizational skills
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on oncology drug development driving demand for specialized regulatory writers Growing complexity in regulatory requirements necessitating expert-level documentation skills Shift towards digital submission formats and automated documentation processes Rising importance of real-world evidence documentation in regulatory submissions

Role Significance

Typically manages 3-5 direct reports with matrix responsibility for 8-12 team members across projects
Senior leadership position with strategic influence on regulatory submissions and documentation processes

Key Projects

Global regulatory submissions for oncology products Clinical trial documentation strategy development Process standardization initiatives Cross-functional collaboration programs

Success Factors

Deep understanding of regulatory requirements across multiple jurisdictions Ability to translate complex scientific data into clear regulatory narratives Strong stakeholder management across global teams Strategic thinking and project leadership capabilities

Market Demand

High demand with limited talent pool due to specialized expertise requirements in both oncology and regulatory writing

Important Skills

Critical Skills

Regulatory documentation expertise for maintaining submission quality and compliance Strategic leadership for driving process improvements and team development Scientific writing capability for translating complex data into clear narratives

Beneficial Skills

Digital documentation tools and automation knowledge Change management experience Clinical trial design understanding Statistical analysis interpretation skills

Unique Aspects

Opportunity to work on cutting-edge oncology treatments
Global role with multi-country flexibility
Strategic position at intersection of medical writing and regulatory affairs
Direct influence on documentation strategy for major drug submissions

Career Growth

2-4 years in role before advancement, depending on business needs and performance

Potential Next Roles

Director of Medical Writing Head of Regulatory Affairs Global Medical Writing Lead

Company Overview

Johnson & Johnson

Johnson & Johnson is a global healthcare leader with significant investments in innovative medicine and medical technology

Top-tier pharmaceutical company with strong oncology pipeline and global regulatory expertise
Strategic European hub role with global influence and cross-regional collaboration
Matrix organization emphasizing innovation, collaboration, and patient-centric approach
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